MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PERMANENT CAUTERY HOOK

Model Number 420183-15

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the black insulation piece on the permanent cautery hook instrument became loose and it started arcing.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected before use with no issues found.The instrument arced within itself with no patient contact.After the arcing event was observed, the instrument was removed and replaced with a backup.Monopolar coagulation energy was activated when the arcing event occurred.The surgeon was transecting the gallbladder.The procedure was completed as planned without any injury or harm to the patient.The were no images or video available.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigation did not replicate nor confirm the reported complaint.Failure analysis found the primary finding of cannot verify external event to be related to the customer reported complaint.The instrument passed the electrical continuity test.The instrument was placed and driven on an in-house system.The instrument passed the recognition an engagement tests.The instrument moved intuitively with full range of motion in all directions.The instrument was fully functional.There was no problem detected.Additional observation(s) not reported by site were that signs of corrosion were found on the instrument bearings.Grip input disk bearings exhibit orange discoloration.The root cause of corroded/contaminated instrument bearings is typically attributed to cleaning/reprocessing techniques.The instrument was also found to have a dislodged ceramic sleeve.No missing material was found.The root cause of dislodged instrument ceramic sleeve is attributed to manufacturing.A review of the instrument log for the permanent cautery hook instrument (pn: 420183-15/ batch-sequence: n10210322 228) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021 with 5 uses remaining.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: it was alleged that the instrument arced.The allegation could be related to the potential for electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: PERMANENT CAUTERY HOOK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 15199265
• MDR Text Key: 297602055
• Report Number: 2955842-2022-13389
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10210322
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: N10210322 228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES